The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

Any therapy for diabetic foot which is routinely practiced and accepted in China

Drug: Standard Therapy

Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Other Name: Drug therapy

Detailed Description:

Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diabetes mellitus Type 2

Age 18 - 75 years

Subject has an Ankle-brachial index < 0.9

Subject has had previous conservative treatment which resulted in little or no improvement

Subject has had no stem cell treatment within the past 6 months

No sufficient response to best standard care delivered for six weeks.

No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01216865

Locations

China, Shandong

Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China, 266003

Sponsors and Collaborators

Qingdao University

Investigators

Study Director:

Yangang Wang, MD Phd

The Affiliated Hospital of Medical College of Qingdao University

More Information

Responsible Party:

Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University